Friday, December 19, 2008

Classen v. Biogen: The Federal Circuit Applies Bilski to the Life Sciences

In a non-precedential opinion, a panel of the Federal Circuit affirmed a lower court’s decision in Classen v. Biogen to invalidate Dr. Classen’s process claims for encompassing patent-ineligible subject matter. I have previously discussed the district court decision in posts to this blog and Patently-O. The claims are directed to methods for determining an optimal immunization schedule based on comparing the observed incidence of immune-mediated disorders in treatment groups subjected to different vaccination schedules.

The decision, in its entirety, states as follows: “In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court’s grant of summary judgment that these claims are invalid under 35 U.S.C. § 101. Dr. Classen’s claims are neither “tied to a particular machine or apparatus” nor do they ‘transform[] a particular article into a different state or thing.’ Bilski, 545 F.3d at 954. Therefore we affirm.”

The opinion ducks important issues. Contrary to the holding, the claims do in fact involve a transformation, e.g., claim 1 of 5,723,283 recites a ‘method . . . which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens . . ..” The immunization of a mammal clearly effects a transformation of a particular article [a mammal] into a different state [a state of induced immunity]. It is inconceivable that this does not constitute a transformation; if that were the case, it would logically follow that all method of treatment claims are patent-ineligible. Rather, the court implicitly must have determined that, in the context of the claims at issue, immunization of a mammal constitutes an “insubstantial extra-solution activity.” In Bilski, the court held that an otherwise patent-ineligible process is not rendered patentable by tagging on an insubstantial additional step. The court could have provided some needed guidance by explaining its basis for determining that the immunization step is insubstantial, but instead the court decided to punt on the issue.

The lower courts decision was less than fully coherent on the basis for its determination that claims are patent-ineligible, at times asserting that the claims are invalid for claiming a mental process, while at other times complaining that that the claims encompass a natural phenomenon. The district court concluded that “[c]learly, the correlation between vaccination schedules and the incidence of immune mediated disorders that Dr. Classen claims to have discovered is a natural phenomenon.” The court provided absolutely no reasoning to support this conclusion. To my mind, it is not at all clear that it can be so blithely assumed that vaccination is a natural phenomenon. That would depend upon how vaccination is defined, but clearly immunization using human-generated vaccines is not something that occurs absent human intervention.

As I discussed in my previous post to Patently-O, to my mind the Bilski machine-transformation test is inappropriate in some cases involving natural phenomena. For example, a claim encompassing photosynthesis in a plant involves a transformation of a particular article [carbon dioxide and water] into a different thing [sugar and oxygen], so it passes the Bilski test. But it cannot be patentable under Supreme Court precedent, since it encompasses a natural phenomenon. I think the Federal Circuit needs to be careful in blinding applying the Bilski test to a claim arguably directed to a natural phenomenon.

A similar case is currently pending before the Federal Circuit, Prometheus v. Mayo, discussed in my earlier posts. The district court in Prometheus also found that the claims at issue encompass an unpatentable natural phenomenon, i.e., the correlation between the amount of a drug metabolite in a patient’s body with the optimal dosage of the drug. Unlike vaccination, which arguably encompasses the natural introduction of an immunogen into a patient’s body, the correlation at issue in Prometheus is entirely the results of the introduction of a non-naturally occurring drug into the patient. While the vaccination in Classen arguably can be interpreted so as to encompass a natural phenomenon, the correlation in Prometheus is not what I would consider to be a natural phenomenon. To hold otherwise would establish dangerous precedent, but the Federal Circuit might never even address the issue if it proceeds to simply apply the Bilski test in a reflexive manner, as appears to have to been the case in Classen.

I would also point out that the Classen decision does not bode well for a host of issued patent claims, particularly genetic diagnostic method claims which purport to broadly encompass any method of identifying a mutation.

Thanks for your analysis. Do you think that the result of the claim (the comparing and determining the better immunization schedule) does not transform a thing explain the ruling, even though the descriptions of the claims do involve a transforming step? Additionally, since the claims are about comparison, thus the immunization step actually does not transform a "particular" article? Thanks for your insight.

We are counsel to Classen Immunotherapies in the recent 12-19-08 CAFC decision on section 101 post Bilski. We filed our Petition for rehearing yesterday and are seeking amicus briefing. We are only seeking to reverse that part of the opinion that states that immunization is not a transformation. We would appreciate if you would be willing to file an amicus brief in support of rehearing.If possible, could you send out this call for amicus briefs.contact me at: joe@zitotlp.com

"Contrary to the holding, the claims do in fact involve a transformation[.]"

Well, eh....no. An element of the claim cites a transformation, but not the claim as a whole.

The claim itself claims a "determining" method, i.e., "[a] method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals[.]"

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Thanks for providing such a beautiful analysis about the decision taken and you have provided also a criticism relate to the decision.

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About Me

I am a law professor at the University of Missouri-Kansas City School of Law. My primary research interests lie at the intersection of biotechnology and intellectual property. This blog provides analysis and commentary on recent developments relevant to this area of the law.